Why it was recalled
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain hydroxythiohomosildenafil, an analogue of sildenafil which is an ingredient in an FDA-approved drug for the treatment of male erectile dysfunction, making this an unapproved new drug.
Product description
ROCK-IT MAN capsules, male sexual stimulant, packaged in 1-count (UPC 8 53447 02003 8) and 2-count (UPC 8 53447 00204 1) blister cards, Distributed by Consumer Concepts.
Lot numbers, UPCs & expiration codes
All product sold between 01/01/13 through 03/27/13.
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-325-2013
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Apr 1, 2013
- FDA report date
- May 22, 2013
- Quantity
- 11,424 blister packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Consumer Concepts, Inc.
Original FDA data
Every field from FDA enforcement report D-325-2013, exactly as published.
Show all FDA fields
- City
- Roscoe
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 64838
- Address
- 5062 Rock Rose Ct.
- Address (line 2)
- Suite #40
- Code information
- All product sold between 01/01/13 through 03/27/13.
- Postal code
- 61073
- Report date
- May 22, 2013
- Product type
- Drugs
- Recall number
- D-325-2013
- Classification
- Class I
- Recalling firm
- Consumer Concepts, Inc.
- Product quantity
- 11,424 blister packs
- Termination date
- May 10, 2018
- Reason for recall
- Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain hydroxythiohomosildenafil, an analogue of sildenafil which is an ingredient in an FDA-approved drug for the treatment of male erectile dysfunction, making this an unapproved new drug.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ROCK-IT MAN capsules, male sexual stimulant, packaged in 1-count (UPC 8 53447 02003 8) and 2-count (UPC 8 53447 00204 1) blister cards, Distributed by Consumer Concepts.
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 1, 2013
- Initial firm notification
- Center classification date
- May 16, 2013